Firm Recalls Supplements Containing Undeclared Erectile Dysfunction Drug

Jack Distribution is voluntarily recalling certain lots of its Rize 2 The Occasion capsules and Rose 4 Her capsules because they contain an undeclared ingredient similar to the active ingredient of an erectile dysfunction (ED) drug.

An FDA analysis found some lots of the dietary supplements, manufactured and packaged in 2007, contained thiomethisosildenafil, an analog of sildenafil, the active ingredient in Pfizer’s Viagra. This chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels, the FDA said.

To read more of this content at FDA News, click here.

FDA Warns About Selenium Megadose in Supplement

April 9, 2008 -- The FDA has found hazardous levels of the mineral selenium in samples of certain flavors of the recalled dietary supplements Total Body Formula and Total Body Mega Formula.

The FDA has received 43 reports of people in nine states -- Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas -- who experienced serious adverse reactions after using these products.

Total Body Essential Nutrition, which distributed the products, has voluntarily recalled the affected products, according to the FDA.

Selenium, a naturally occurring mineral, can boost the immune system, but it's only needed in very small amounts for good health. Generally, normal consumption of food and water provides adequate selenium to support good health.

Too much selenium is known to cause symptoms such as hair loss, muscle cramps, diarrhea, joint pain, fatigue, fingernail loss, and skin blisters.

To read more of this content at WebMD, click here.

FL. Dept of Health Advises FDA of Adverse Reactions to Dietary Supplement

The Florida Department of Health has advised the Food and Drug Administration (FDA) of 23 cases of adverse reactions to a liquid supplement distributed by Total Body Essential Nutrition based in Atlanta. As a result the FDA has issued a consumer alert warning consumers to immediately discontinue using the Tropical Orange and Peach Nectar flavored "Total Body Formula" and the Orange/Tangerine flavored "Total Body Mega Formula" supplements.

The symptoms being reported include "siginificant hair loss, muscle cramps, diarrhea, joint pain and fatigue" after using the products for as little as seven days. The source of these reactions has yet to be determined and the FDA will issue more information as it becomes available.

To read more of this content at The Florida Injury Board, click here.

Law to Help Regulate U.S. Supplement Industry Now in Effect

The Dietary Supplement and Nonprescription Drug Consumer Protection Act has gone into effect a year after it was signed by President Bush.

The law requires manufacturers and distributors of dietary supplements and OTC drugs to report all serious adverse events associated with the use of their products to the FDA. It also requires them to keep records of other adverse events.

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